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Case Studies & Blogs
Pre-specify, or explain yourself later
Two FDA advisory committee meetings, held a day apart, expose two distinct pre-specification failures: a randomised trial whose analysis plan was rewritten after unblinding, and a single-arm trial that never properly specified its external control arm.
2 days ago5 min read
The unfinished business of target trial emulation
At GetReal Institute's 2026 conference in Utrecht, stakeholders discussed the future of the target trial framework. Adigens Health led the workshop—here's what's at stake, and why a white paper is coming.
Jul 73 min read
EHDS: framework in place, infrastructure still missing
New guidance from TEHDAS2 clarifies how the European Health Data Space will govern pharmaceutical access to real-world data. The problems it leaves unresolved matter more for observational studies built in a target trial framework than the problems it solves.
Jun 236 min read
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